[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"mss\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:mss":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,48,70,95,124,165,189,213],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100585873","phase-2-scrtmfolfox6pd-1-antibody-and-targeted-therapy-for-high-risk-pmmrmss-rectal-cancercrit-100585873",false,"NCT06908031","SCRT+mFOLFOX6+PD-1 Antibody and Targeted Therapy for High-Risk pMMR\u002FMSS Rectal Cancer(CRIT)","Short-Course Radiotherapy Combined With mFOLFOX6, PD-1 Antibody and Cetuximab (for RAS\u002FBRAF Wild-Type)\u002FBevacizumab (for RAS\u002FBRAF Mutant) in High-Risk pMMR\u002FMSS Rectal Adenocarcinoma: a Prospective, Multicenter Phase II Study(CRIT)","CRIT","Inclusion Criteria:\n\n1. Before conducting procedures related to the research protocol but not part of routine care, written informed consent, voluntarily signed and dated by the subject, must be obtained in accordance with regulations and institutional guidelines.\n2. Age 18-75 years.\n3. Histologically or cytologically confirmed pMMR\u002FMSS rectal adenocarcinoma; all other histological types are excluded.\n4. Distance from the lower margin of the rectal tumor to the anal verge ≤10 cm.\n5. Clinical staging with high-risk factors, including cT3Nx, EMVI(+), or cT4, ±MRF(+), ±EMVI(+).\n6. No evidence of distant metastasis before treatment.\n7. No prior anti-cancer treatment (radiotherapy, chemotherapy, targeted therapy, or immunotherapy).\n8. ECOG performance status of 0-1.\n9. Peripheral blood counts and liver and kidney function within the following allowable ranges (tested within 15 days before the start of treatment):\n\n   1. White blood cells (WBC) ≥3.0×10\\^9\u002FL or absolute neutrophil count (ANC) ≥1.5×10\\^9\u002FL;\n   2. Hemoglobin (HGB) ≥80 g\u002FL;\n   3. Platelets (PLT) ≥100×10\\^9\u002FL;\n   4. Liver transaminases (AST\u002FALT) \\\u003C3.0 times the upper limit of the normal range;\n   5. Total bilirubin (TBIL) \\\u003C1.5 times the upper limit of the normal range;\n   6. Creatinine (CREAT) \\\u003C1.5 times the upper limit of the normal range.\n10. No history of other malignancies; not pregnant or breastfeeding, and effective contraception must be used during the study period and for 6 months after the last dose.\n\nExclusion Criteria:\n\n1. Patients with a history of severe drug allergies (including allergies to platinum agents, 5-FU, LV, and 5-HT3 receptor antagonists);\n2. Patients who have participated in or are currently participating in other clinical trials within 4 weeks prior to enrollment;\n3. A history of having received anti-PD-1, PD-L1, PD-L2, CTLA-4, or any other specific T-cell costimulatory or checkpoint pathway-targeted therapy;\n4. Severe electrolyte abnormalities;\n5. Presence of gastrointestinal diseases, such as active ulcers in the stomach or duodenum, ulcerative colitis, or tumors with active bleeding that have not been resected; or other conditions that may lead to gastrointestinal bleeding or perforation; or gastrointestinal perforation that has not healed after surgical treatment;\n6. History of arterial thrombosis or deep vein thrombosis within 6 months; history of bleeding or evidence of bleeding tendency within 2 months; or patients receiving high-dose anticoagulation therapy;\n7. Pregnant or breastfeeding women, or women of childbearing potential with a positive pregnancy test before the first dose; or female participants and their partners who are unwilling to strictly practice contraception during the study period;\n8. Presence of other active malignancies (except for malignancies that have been treated with curative intent and have been disease-free for more than 3 years, or in situ cancers that can be cured with adequate treatment);\n9. Presence of severe ECG abnormalities or active coronary artery disease, severe\u002Funstable angina, newly diagnosed angina or myocardial infarction within 12 months prior to study entry, or New York Heart Association (NYHA) Class II or higher congestive heart failure;\n10. Patients with active infections (infections causing fever above 38°C);\n11. Patients with uncontrolled hypercalcemia, hypertension, or diabetes;\n12. Patients with severe pulmonary diseases (interstitial pneumonia, pulmonary fibrosis, severe emphysema, etc.);\n13. Patients with psychiatric disorders that may affect clinical treatment or a history of central nervous system diseases;\n14. Patients with severe complications (bowel obstruction, renal insufficiency, hepatic insufficiency, cerebrovascular disorders, etc.);\n15. Presence of any CTCAE Grade 2 or higher toxicity caused by previous treatments that has not resolved (excluding anemia, alopecia, and skin pigmentation);\n16. Any unstable medical condition that may affect patient safety and compliance with the study;\n17. Patients deemed by the investigator as unsuitable for participation in this clinical trial.","ALL","18 Years","75 Years",{"count":21,"type":22},49,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","To explore the efficacy and safety of short-course radiotherapy combined with mFOLFOX6, PD-1 monoclonal antibody and cetuximab (for RAS\u002FBRAF Wild-Type)\u002Fbevacizumab (for RAS\u002FBRAF Mutant) in High-Risk pMMR\u002FMSS Rectal Adenocarcinoma through a prospective study, providing high-level evidence-based medical evidence for the use in the treatment of high-risk rectal cancer.",[28,29,30],"Rectal Adenocarcinoma","High-Risk Cancer","MSS",[32,33,34],"Short-Course Radiotherapy","Targeting Therapy","Immunotherapy","RECRUITING","2026-06-30",{"date":38,"type":39},"2026-07-01","ACTUAL",{"date":41,"type":39},"2025-04-02",{"date":43,"type":22},"2027-04-01",{"name":45,"class":46},"Sixth Affiliated Hospital, Sun Yat-sen University","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":56,"targetDuration":4,"studyType":23,"phases":58,"briefSummary":60,"conditions":61,"keywords":62,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":47},"100635185","phase-3-scrt--chemo-targeted-immuno-neoadjuvant-therapy-for-high-risk-pmmrmss-rc-100635185","NCT07549399","SCRT + Chemo Targeted Immuno-neoadjuvant Therapy for High-risk pMMR\u002FMSS RC","Short-Course Radiotherapy Combined With mFOLFOX6, PD-1 Antibody and Cetuximab (for RAS\u002FBRAF Wild-Type)\u002FBevacizumab (for RAS\u002FBRAF Mutant) in High-Risk pMMR\u002FMSS Rectal Adenocarcinoma: a Phase III Randomized Controlled Trial","CRITⅡ","Inclusion Criteria:\n\n1. Before conducting procedures related to the research protocol but not part of routine care, written informed consent, voluntarily signed and dated by the subject, must be obtained in accordance with regulations and institutional guidelines.\n2. Age 18-75 years.\n3. Histologically or cytologically confirmed pMMR\u002FMSS rectal adenocarcinoma; all other histological types are excluded.\n4. Distance from the lower margin of the rectal tumor to the anal verge ≤10 cm.\n5. Clinical staging with high-risk factors, including cT3Nx, EMVI(+), or cT4, ±MRF(+), ±EMVI(+).\n6. No evidence of distant metastasis before treatment.\n7. No prior anti-cancer treatment (radiotherapy, chemotherapy, targeted therapy, or immunotherapy).\n8. ECOG performance status of 0-1.\n9. Peripheral blood counts and liver and kidney function within the following allowable ranges (tested within 15 days before the start of treatment):\n\n   * White blood cells (WBC) ≥3.0×10\\^9\u002FL or absolute neutrophil count (ANC) ≥1.5×10\\^9\u002FL;\n\n     * Hemoglobin (HGB) ≥80 g\u002FL; ③Platelets (PLT) ≥100×10\\^9\u002FL; ④Liver transaminases (AST\u002FALT) \\\u003C3.0 times the upper limit of the normal range; ⑤Total bilirubin (TBIL) \\\u003C1.5 times the upper limit of the normal range; ⑥Creatinine (CREAT) \\\u003C1.5 times the upper limit of the normal range.\n10. No history of other malignancies; not pregnant or breastfeeding, and effective contraception must be used during the study period and for 6 months after the last dose.\n\nExclusion Criteria:\n\n1. Patients with a history of severe drug allergies (including allergies to platinum agents, 5-FU, LV, and 5-HT3 receptor antagonists);\n2. Patients who have participated in or are currently participating in other clinical trials within 4 weeks prior to enrollment;\n3. A history of having received anti-PD-1, PD-L1, PD-L2, CTLA-4, or any other specific T-cell costimulatory or checkpoint pathway-targeted therapy;\n4. Severe electrolyte abnormalities;\n5. Presence of gastrointestinal diseases, such as active ulcers in the stomach or duodenum, ulcerative colitis, or tumors with active bleeding that have not been resected; or other conditions that may lead to gastrointestinal bleeding or perforation; or gastrointestinal perforation that has not healed after surgical treatment;\n6. History of arterial thrombosis or deep vein thrombosis within 6 months; history of bleeding or evidence of bleeding tendency within 2 months; or patients receiving high-dose anticoagulation therapy;\n7. Pregnant or breastfeeding women, or women of childbearing potential with a positive pregnancy test before the first dose; or female participants and their partners who are unwilling to strictly practice contraception during the study period;\n8. Presence of other active malignancies (except for malignancies that have been treated with curative intent and have been disease-free for more than 3 years, or in situ cancers that can be cured with adequate treatment);\n9. Presence of severe ECG abnormalities or active coronary artery disease, severe\u002Funstable angina, newly diagnosed angina or myocardial infarction within 12 months prior to study entry, or New York Heart Association (NYHA) Class II or higher congestive heart failure;\n10. Patients with active infections (infections causing fever above 38°C);\n11. Patients with uncontrolled hypercalcemia, hypertension, or diabetes;\n12. Patients with severe pulmonary diseases (interstitial pneumonia, pulmonary fibrosis, severe emphysema, etc.);\n13. Patients with psychiatric disorders that may affect clinical treatment or a history of central nervous system diseases;\n14. Patients with severe complications (bowel obstruction, renal insufficiency, hepatic insufficiency, cerebrovascular disorders, etc.);\n15. Presence of any CTCAE Grade 2 or higher toxicity caused by previous treatments that has not resolved (excluding anemia, alopecia, and skin pigmentation);\n16. Any unstable medical condition that may affect patient safety and compliance with the study;\n17. Patients deemed by the investigator as unsuitable for participation in this clinical trial.",{"count":57,"type":22},204,[59],"PHASE3","To explore the efficacy and safety of an intensified treatment regimen consisting of short-course radiotherapy followed by mFOLFOX6 chemotherapy combined with precise targeted therapy (based on RAS\u002FBRAF status: cetuximab for wild-type, bevacizumab for mutant) and a PD-1 monoclonal antibody, compared with short-course radiotherapy followed by mFOLFOX6 chemotherapy alone, in high-risk locally advanced pMMR\u002FMSS rectal adenocarcinoma through a prospective, randomized controlled phase III clinical study, providing high-level evidence-based medical evidence to establish a superior neoadjuvant treatment strategy for this population.",[28,29,30],[32,33,34],"2026-06-29",{"date":38,"type":39},{"date":66,"type":39},"2026-05-20",{"date":68,"type":22},"2029-04-30",{"name":45,"class":46},{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":77,"targetDuration":4,"studyType":23,"phases":79,"briefSummary":80,"conditions":81,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":47},"100581422","phase-2-scrt-capeox-serplulimab-for-msspmmr-rectal-cancer-with-oligometastases-100581422","NCT06850103","SCRT-CAPEOX-Serplulimab for MSS\u002FpMMR Rectal Cancer With Oligometastases","A Phase II Exploratory Multicenter Randomized Controlled Clinical Trial to Evaluate the Effectiveness of Neoadjuvant Short-Course Radiotherapy (SCRT) Followed by CAPEOX Chemotherapy and Serplulimab in Microsatellite Stable (MSS) or Proficient Mismatch Repair (pMMR) Rectal Cancer With Synchronous Oligometastases","Inclusion Criteria:\n\n\\- Has signed the written Informed Consent Form (ICF) and is able to comply with protocol-specified visits and procedures.\n\nAge between 18-75 years.\n\nHistologically confirmed primary rectal adenocarcinoma, with MRI showing tumor location within 10cm from the anal verge.\n\nSynchronous oligometastatic rectal cancer confirmed by comprehensive imaging evaluation (contrast-enhanced CT, contrast-enhanced MRI, PET-CT, etc.), with ≤2 metastatic sites and ≤5 total metastatic lesions.\n\nMicrosatellite stability status confirmed as MSS (using the NCI-recommended 5 microsatellite markers: BAT25, BAT26, D5S346, D2S123, D17S250) or proficient mismatch repair (pMMR) status confirmed by immunohistochemistry showing positive nuclear expression of all 4 MMR proteins (MLH1, MSH2, MSH6, PMS2).\n\nAt least one measurable lesion according to RECIST v1.1 criteria.\n\nEastern Cooperative Oncology Group performance status (ECOG PS) of 0-1.\n\nAdequate organ function and bone marrow reserve, defined as follows:\n\nComplete blood count:\n\nAbsolute Neutrophil Count (ANC) ≥1.5×109\u002FL Platelet count (PLT) ≥100×109\u002FL Hemoglobin (HGB) ≥10.0g\u002FdL\n\nLiver function:\n\nTotal Bilirubin (TBIL) ≤1.5×Upper Limit of Normal (ULN) Alanine transaminase (ALT) and Aspartate aminotransferase (AST) ≤3×ULN Serum albumin (ALB) ≥35 g\u002FL\n\nRenal function:\n\nSerum creatinine ≤1.5×ULN or creatinine clearance ≥50 mL\u002Fmin (calculated using Cockcroft-Gault formula \\[see Appendix 3\\] or standard 24-hour urine collection method) Urine protein by dipstick \\\u003C2+ For subjects with baseline urine protein ≥2+ by dipstick, 24-hour urine protein must be \\\u003C1g\n\nCoagulation:\n\nInternational Normalized Ratio (INR) ≤1.5 Activated partial thromboplastin time (APTT) ≤1.5×ULN Certain anticoagulant medications (such as antiplatelet agents, vitamin K antagonists) must be discontinued 7-14 days before surgery and replaced with alternative medications (such as low molecular weight heparin) No concurrent serious diseases that would threaten subject survival (leading to expected survival \\\u003C5 years).\n\nWomen of childbearing potential and men whose partners are of childbearing potential must use effective contraception during the entire treatment period and for 6 months after treatment completion. Female subjects must either have evidence of post-menopausal status, or if pre-menopausal, have a negative urine or serum pregnancy test.\n\nExclusion Criteria:\n\n\\- More than 2 metastatic sites or more than 5 total metastatic lesions confirmed by imaging evaluation.\n\nPrior anti-tumor therapy for the study disease, including surgery, radiotherapy, chemotherapy, targeted therapy, or immunotherapy.\n\nPrevious treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibodies, or any other drugs targeting T-cell co-stimulation or immune checkpoint pathways (e.g., OX40, CD137), or adoptive cell immunotherapy.\n\nConcurrent participation in another clinical trial, except for observational (non-interventional) studies or survival follow-up phase of interventional studies.\n\nReceipt of any investigational drug within 4 weeks prior to first dose of study drug.\n\nHistory of blood transfusion or use of G-CSF, GM-CSF, EPO, TPO, or IL-11 within 14 days prior to screening laboratory tests.\n\nUse of immunosuppressive medications within 4 weeks prior to first dose of study drug, excluding:\n\nIntranasal inhaled corticosteroids or local steroid injections Systemic corticosteroids at ≤10 mg\u002Fday prednisone equivalent Corticosteroids as premedication for allergic reactions (e.g., CT contrast) Traditional Chinese medicines with anti-tumor indications or immunomodulatory effects within 1 week prior to first dose Receipt of live or attenuated vaccines within 4 weeks prior to first dose or anticipated during the study period.\n\nMajor surgery within 4 weeks prior to first dose (e.g., craniotomy, thoracotomy, or laparotomy), anticipated major surgery during treatment (excluding protocol-specified rectal cancer surgery), or presence of unhealed wounds, ulcers, or fractures.\n\nKnown active or suspected autoimmune disease or history within past 2 years (exceptions: eczema, vitiligo, psoriasis, alopecia, or Graves' disease not requiring systemic treatment in past 2 years; hypothyroidism requiring only hormone replacement; Type I diabetes requiring only insulin).\n\nKnown history of primary immunodeficiency.\n\nActive tuberculosis, current anti-TB treatment, or anti-TB treatment within 1 year prior to first dose.\n\nKnown history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.\n\nKnown allergy to capecitabine, oxaliplatin, serplulimab, or other monoclonal antibody components.\n\nClinically significant ascites, pleural effusion requiring intervention, or symptomatic pericardial effusion requiring drainage.\n\nHIV infection (HIV antibody positive).\n\nAcute or chronic active hepatitis B (defined as HBsAg positive or HBcAb positive only with HBV DNA ≥2000 IU\u002FmL or ≥1×104 copies\u002FmL) or hepatitis C (defined as HCV antibody positive with detectable HCV RNA).\n\nActive syphilis infection requiring treatment.\n\nSevere infection within 4 weeks prior to first dose, including but not limited to hospitalization for infection, bacteremia, or severe pneumonia; therapeutic oral or IV antibiotics within two weeks prior to first dose.\n\nSymptomatic congestive heart failure (NYHA class II-IV) or LVEF \\\u003C50%; symptomatic or uncontrolled arrhythmias; congenital long QT syndrome or QTc \\>500 ms at screening (Fridericia's formula).\n\nUncontrolled hypertension (SBP ≥160 mmHg or DBP ≥100 mmHg) despite standard therapy, history of hypertensive crisis or encephalopathy.\n\nSevere bleeding diathesis or coagulation disorders, or current thrombolytic therapy.\n\nAny arterial thromboembolic events within 6 months prior to first dose, including myocardial infarction, unstable angina, stroke, or TIA.\n\nEsophageal or gastric varices requiring immediate intervention; high bleeding risk subjects require endoscopic evaluation within 3 months before enrollment.\n\nHistory of GI perforation and\u002For fistula within 6 months prior to first dose.\n\nLife-threatening bleeding event within 3 months prior to first dose, or Grade 3\u002F4 GI\u002Fvariceal bleeding requiring transfusion, endoscopy, or surgery.\n\nHistory of DVT, PE, or other serious thromboembolism within 3 months prior to first dose (excluding catheter-related thrombosis or superficial thrombosis).\n\nUncontrolled metabolic disorders or other non-malignant conditions causing high medical risk or uncertain survival evaluation.\n\nHepatic encephalopathy, hepatorenal syndrome, or Child-Pugh B \\>7 or worse cirrhosis.\n\nBowel obstruction (including incomplete requiring parenteral nutrition); conditions with perforation risk; history of extensive bowel resection, Crohn's disease, ulcerative colitis, or chronic diarrhea.\n\nInterstitial lung disease requiring treatment; history of pulmonary fibrosis, pneumoconiosis, drug-induced pneumonitis, organizing pneumonia, or severe pulmonary dysfunction.\n\nSignificant malnutrition (5% weight loss within 1 month or 15% within 3 months of consent, or \\>50% reduced intake for 1 week), unless corrected for ≥4 weeks before first dose.\n\nHistory of other primary malignancies, except:\n\nCured malignancies with ≥2 years disease-free and low recurrence risk Well-treated non-melanoma skin cancer or lentigo maligna Well-treated carcinoma in situ\n\nOther acute or chronic conditions that could:\n\nIncrease study participation risks Interfere with result interpretation Make subject unsuitable per investigator judgment Neurological, psychiatric, or social conditions affecting compliance or safety assessment.\n\nAlcohol, drug, or substance abuse affecting drug administration or toxicity analysis.\n\nPregnant or breastfeeding women.\n\nConditions interfering with medication management or toxicity analysis due to alcohol, drug, or substance use.\n\nPregnancy or breastfeeding.",{"count":78,"type":22},51,[25],"Background and Significance:\n\nColorectal cancer (CRC) ranks as the third most common cancer and the second leading cause of cancer-related deaths globally. Despite improved early screening rates, a significant proportion of newly diagnosed CRC patients present with synchronous metastases, predominantly liver metastases. The concept of oligometastases, introduced by Hellman and Weichselbaum in 1995, describes a transitional state between localized disease and widespread metastases, characterized by limited metastatic lesions (typically 1-5) confined to 1-2 organs.\n\nCurrent Treatment Landscape:\n\nThe management of oligometastatic disease combines local therapeutic approaches (surgery, radiotherapy, radiofrequency ablation) with systemic treatments, aiming to achieve No Evidence of Disease (NED) status. The ESMO guidelines officially categorized metastatic CRC into oligometastatic and widespread metastatic states in 2016, emphasizing the importance of integrated local and systemic treatments for oligometastatic colorectal liver metastases (CRLM).\n\nTreatment Evolution and Challenges:\n\nWhile the EPOC study established CAPEOX neoadjuvant chemotherapy followed by R0 resection as the standard treatment for initially resectable CRLM, patients with synchronous rectal cancer oligometastases present unique challenges due to complex local anatomy and high local recurrence risks. Although various neoadjuvant approaches, including Total Neoadjuvant Therapy (TNT), have been studied, they have not demonstrated significant long-term survival benefits, primarily because distant metastases impact survival more significantly than local recurrence.\n\nInnovative Approach:\n\nRecent success with Immunotherapy-Based Total Neoadjuvant Therapy (iTNT) in microsatellite stable\u002Fproficient mismatch repair (MSS\u002FpMMR) locally advanced rectal cancer has shown promising results. Short-course radiotherapy (SCRT) combined with chemotherapy and immunotherapy has demonstrated superior efficacy trends, attributed to radiation's immune-activating effects on both local and distant tumor microenvironments.\n\nResearch Objective:\n\nThis project aims to evaluate the effectiveness of iTNT combined with SCRT in MSS\u002FpMMR rectal cancer patients with synchronous oligometastases. The novel approach integrates SCRT with CAPEOX chemotherapy and Serplulimab, potentially improving complete response rates, organ preservation opportunities, and overall treatment efficacy while reducing recurrence risks. This pioneering study represents the first investigation of iTNT in synchronous rectal cancer oligometastases, offering a potentially transformative treatment strategy for this challenging patient population.\n\nResearch Innovation:\n\nThe study uniquely combines SCRT, CAPEOX chemotherapy, and Serplulimab in a neoadjuvant setting for MSS\u002FpMMR synchronous rectal cancer oligometastases, addressing an unmet clinical need and potentially establishing a new treatment paradigm in this field.",[82,83,84,30,85],"Colorectal Carcinoma","Oligometastases","pMMR","iTNT","2026-03-22",{"date":88,"type":39},"2026-03-25",{"date":90,"type":39},"2025-04-22",{"date":92,"type":22},"2032-12",{"name":94,"class":46},"First Affiliated Hospital of Zhejiang University",{"id":96,"slug":97,"hasResults":11,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":4,"eligibilityCriteria":101,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":102,"targetDuration":4,"studyType":23,"phases":104,"briefSummary":105,"conditions":106,"keywords":109,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":47},"100495479","phase-2-serplulimab-combined-with-capeox--celecoxib-as-neoadjuvant-treatment-for-locally-advanced-rectal-cancer-100495479","NCT05731726","Serplulimab Combined With CAPEOX + Celecoxib as Neoadjuvant Treatment for Locally Advanced Rectal Cancer","A Phase II Study to Explore the Neoadjuvant Treatment of Serplulimab Combined With CAPEOX + Celecoxib in the Treatment of Locally Advanced Rectal Cancer","Inclusion Criteria:\n\n1. Willing and able to provide written informed consent.\n2. Male or female subjects ≧ 18 years ≦ 75 of age.\n3. Histological or cytological documentation of adenocarcinoma of the rectum.\n4. No previous any systemic anticancer therapy for rectal cancer disease.\n5. The lower margin of the tumor is less than 10cm from the anus verge.\n6. cT2N1-2M0, cT3N0-2M0, cT4N0-2M0 MSS with MRF(-) assessed by MRI.\n7. Primary tumor can be detected by CT or MRI.\n8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n9. Eligible tumor tissues were identified for MSI\u002FMMR assays.\n10. Hepatitis B Surface Antigen (HBsAg) (-).\n11. If HBsAg (+) , HBV-DNA must be less than 2500 copies\u002FmL or 500 IU\u002FmL to be enrolled.\n12. Patients with HCV antibody (-) or HCV-RNA negative can be enrolled. Aspartate aminotransferase (AST) must be ≤ 3 x ULN for the lab. If HCV-RNA is positive, patients with both alanine aminotransferase (ALT) and aspartate aminotransferase (AST) performed ≤3×ULN could be enrolled. Patients infected with both hepatitis B virus and hepatitis C virus should be excluded (positive for HBsAg or HBcAb and positive for HCV antibodies).\n\nExclusion Criteria:\n\n1. Patients with recurrent rectal cancer or a history of pelvic radiotherapy.\n2. Patients with a history of inflammatory bowel disease.\n3. Patients with acquired immunodeficiency syndrome (AIDS-related illnesses) or known human immunodeficiency virus (HIV) disease (HIV1 antibody, HIV2 antibody, HTLV1 antibody positive) should be excluded.\n4. Patients who are preparing for or have previously received an organ or bone marrow transplant.\n5. History of myocardial infarction, poorly controlled arrhythmias (including QTc interval ≥470 ms in women) in the 6 months prior to enrollment (QTc interval calculated by Fridericia formula).\n6. According to New York College of Cardiology (NYHA) standards for Grade III-IV cardiac insufficiency or cardiac color ultrasound: left ventricular ejection fraction (LVEF) \\\u003C50%.Poor hypertension control (systolic blood pressure ≥150 mmHg and\u002For diastolic blood pressure ≥100 mmHg), a past hypertensive crisis or hypertensive encephalopathy.\n7. Poor hypertension control (systolic blood pressure ≥150 mmHg and\u002For diastolic blood pressure ≥100 mmHg), a past hypertensive crisis or hypertensive encephalopathy.\n8. Patients had undergone major surgery within 28 days prior to enrollment. Patients with tumor biopsy or lymph node dissection biopsy were admitted. Patients undergoing enterostomy due to intestinal obstruction were admitted.\n9. The patients had previously been treated with other antibodies\u002Fdrugs that target immune checkpoints, such as PD-1, PD-L1, and cytotoxic T lymphocyte-associated Antigen 4 (CTLA-4).\n10. Patients are participating in other clinical studies, or plan to start this study treatment less than 14 days from the end of the previous clinical study.\n11. Uncontrolled tumor-related pain.\n12. A known history of severe allergy to any monoclonal antibody.\n13. Known to be allergic or intolerance to any oxaliplatin and capecitabine ingredients.\n14. Pregnant or lactating women.\n15. The investigators determined that the patient had other factors that might have led to the early termination of the study.",{"count":103,"type":22},50,[25],"Colorectal cancer of Mismatch Repair-proficient (pMMR)\u002F Microsatellite Stability (MSS) accounts for approximately 85% of all colorectal cancer patients, which might be insensitive to immunotherapy. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy, such as CAPEOX regimen, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Celecoxib, a COX-2 inhibitor, can improve the immune microenvironment and have a potential to synergy with immunotherapy. Chemotherapy can improve the immunogenicity of cancer cells that might enhance the efficacy of immunotherapy. The aim of this study is to explore whether chemotherapy and cyclooxygenase (COX) inhibitors combined with anti-PD-1 monoclonal antibody (mAb) could improve efficacy for resectable colorectal cancer patient with the pMMR\u002FMSS phenotype.",[84,30,107,108],"MSI-L","Locally Advanced Rectal Carcinoma",[110,111,112,113,114],"Rectal cancer","Serplulimab","Celecoxib","CAPEOX","neoadjuvant therapy","2026-03-03",{"date":117,"type":39},"2026-03-05",{"date":119,"type":39},"2023-02-22",{"date":121,"type":22},"2026-12-30",{"name":123,"class":46},"Zhejiang University",{"id":125,"slug":126,"hasResults":11,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":130,"eligibilityCriteria":131,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":132,"enrollmentInfo":133,"targetDuration":4,"studyType":23,"phases":135,"briefSummary":137,"conditions":138,"keywords":150,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":47},"100593065","phase-1-intra-tumoral-it-injection-of-vvdd-hil2-2-rg-1-for-metastatic-gastrointestinal-and-peritoneal-tumors-100593065","NCT07001592","Intra-tumoral (IT) Injection of vvDD-hIL2-2-RG-1 for Metastatic Gastrointestinal and Peritoneal Tumors","A Phase I Dose-Escalation Trial of vvDD-hIL2-2-RG-1 (Vaccina Virus Double Deleted) Administered by Intra-tumoral (IT) Injection for Metastatic Gastrointestinal and Peritoneal Tumors","RIOT3","Inclusion Criteria:\n\n1. Males or females age, 18 to \\\u003C 70 years at the time of consent\n2. Histologically confirmed metastases from gastrointestinal tumors with molecular determinants for MSI and KRAS.\n3. For microsatellite stable (MSS) tumors, subjects must have failed (or be ineligible for) standard 1st and 2nd line chemotherapy. For microsatellite instability-high (MSI-H) tumors, subjects must also have failed (or be ineligible for) systemic immunotherapy.\n4. Karnofsky Performance Status (KPS) of \\> 70\n5. Anticipated survival of at least 12 weeks.\n6. Written informed consent in accordance with national, local, and institutional guidelines obtained prior to any study procedures (subject or subject's legally authorized representative (LAR) must have the ability to understand and willingness to sign a written informed consent).\n7. Adequate bone marrow function: WBC \\> 2,000 and \\\u003C50,000 cells\u002Fmm3, ANC \\> 1,000 cells\u002Fmm3, hemoglobin \\>8 g\u002FdL, and platelet count \\>100,000 cells\u002Fmm3.\n8. Adequate renal function: serum creatinine level ≤ 2xULN\n9. Adequate liver function: Serum bilirubin \\\u003C 1.5 x ULN\n10. Acceptable coagulation status: INR \\\u003C ULN +15%. All patients must be able to suspend anticoagulant therapy for study specific biopsies and intra-tumoral injection.\n11. Women of childbearing potential (defined as all women physiologically capable of becoming pregnant) must have negative serum or urine pregnancy test.\n12. If sexually active, to prevent pregnancy and to prevent the spread of virus, subject must use an acceptable method of contraception as well as barrier contraception from screening through 6 weeks following study treatment with vvDD-hIL-2-RG-1.\n13. Subjects must be willing to comply with all study procedures, requirements, adhere to post-treatment care instructions and follow-up examinations.\n14. Have measurable disease based on RECIST 1.1 criteria.\n15. Have at least one tumor at least 1 cm in diameter amenable to safe intra-tumoral injection.\n\nExclusion Criteria:\n\n1. Pregnant or nursing an infant.\n2. Systemic corticosteroid or other immunosuppressive medication use within 2 weeks of the study treatment.\n3. Significant immunodeficiency (e.g. due to underlying illness and\u002For medication) in subject or household contacts (must be able to avoid household contact with immunodeficient person for 3 weeks).\n4. Clinically significant active infection or uncontrolled medical condition (e.g., pulmonary, neurological, cardiovascular, gastrointestinal, genitourinary) considered high risk for investigational new drug treatment, per investigator discretion.\n5. Active eczema or psoriasis or other inflammatory skin conditions\n6. Unstable cardiac disease which includes but is not limited to any of the following within 6 months prior to study entry: myocardial infarction (MI), unstable angina, congestive heart failure, myocarditis, ventricular arrhythmias diagnosed and requiring medication.\n\n   * New York Heart Association functional class III-IV heart failure on active treatment\n   * Pulse oximetry of \\\u003C 90% in room air at rest\n7. Subjects who have received radiation, chemotherapy or other potentially immunosuppressive therapy within 2 weeks prior to study screening and within 4 weeks prior to anticipated vvDD-hIL-2-RG-1 treatment.\n8. Experienced a severe systemic reaction or side-effect as a result of a previous smallpox vaccination.\n9. Subjects who, in the opinion of the Investigator, have a medical condition that would subject the subject to prohibitive risk by participation in this study, or who may be unable to safely complete the required tumor biopsies.\n10. Subjects with household contacts who are children \\\u003C 5 years old, have active eczema, psoriasis or other inflammatory skin conditions or have a significant immunodeficiency due to underlying illness (e.g. human immunodeficiency virus) and\u002For medication (e.g. systemic corticosteroids) will be excluded unless alternate living arrangements can be made during the subject's active dosing period and for three weeks following the study medication.\n11. Vaccination with a live virus in the previous 60 days prior to Day 0.\n12. Inability or unwillingness to give informed consent.\n13. Is unable or unwilling to comply with protocol follow-up requirements. -","69 Years",{"count":134,"type":22},18,[136],"PHASE1","This research study aims to evaluate the safety and determine the optimal dose of a new experimental drug, vvDD-hIL2 (vaccinia virus double-deleted human interleukin 2), in patients with advanced abdominal cancer. The study will involve three dose levels, with three to six patients enrolled at each level.\n\nvvDD-hIL2 is a genetically modified vaccinia virus, derived from the virus previously used for smallpox vaccination. The modification is intended to target and destroy tumors while minimizing harm to healthy tissues by stimulating the body's immune response.\n\nParticipants will receive an injection of vvDD-hIL2 directly into their abdominal tumors at AHN West Penn. The study team will monitor for side effects and assess tumor response to the treatment.\n\nActive participation will last up to two months, involving seven clinic visits and approximately four lab visits at AHN West Penn Hospital. Visits will include standard of care procedures as well as study-specific tests and exams. Most visits will last one to two hours, with some extending to two to three hours. The drug administration day will require a twelve-hour visit.\n\nEffectiveness and side effects will be evaluated through blood draws, oral swabs, urinalysis and tissue biopsies. Tissue samples will be used for genomic analysis and stored for potential future research. Data collected may also be used for future research purposes.\n\nPrevious human trials of vvDD-hIL2 have reported side effects such as pain, rash or inflammation at the injection site, low-grade fevers, flu-like symptoms, and fatigue. There is a rare risk of rash transmission to close contacts with skin openings, and information on limiting contact and managing rash development will be provided.",[139,140,141,142,143,30,144,145,146,147,148,149],"Gastric Neoplasms","Esophageal Cancer","Liver Cancer","Liver Metastasis","MSS-CRC","Gastric Adenocarcinoma","Peritoneal Cancer","Peritoneal Carcinoma","Peritoneal Metastases","MSI-H","Gastric Cancer",[151,152,153,154,155],"Oncolytic virus","vaccinia","immunotherapy","intra-tumoral","intra-peritoneal","2025-06-02",{"date":158,"type":39},"2025-06-03",{"date":160,"type":39},"2025-05-06",{"date":162,"type":22},"2028-05",{"name":164,"class":46},"Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)",{"id":166,"slug":167,"hasResults":11,"nctId":168,"briefTitle":169,"officialTitle":170,"acronym":4,"eligibilityCriteria":171,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":172,"targetDuration":4,"studyType":23,"phases":174,"briefSummary":175,"conditions":176,"keywords":4,"overallStatus":179,"whyStopped":4,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":181,"startDateStruct":183,"completionDateStruct":185,"leadSponsor":187,"locationsCount":47},"100561698","phase-2-lvosidenib-ak112-combined-with-capeox-and-radiotherapy-in-patients-with-unresectable-metastatic-mss-type-colorectal-cancer-100561698","NCT06593548","Lvosidenib (AK112) Combined With CapeOX and Radiotherapy in Patients With Unresectable Metastatic MSS-type Colorectal Cancer","A Prospective, Single-arm, Single-center, Phase II Clinical Study of Ivosidenib (AK112) Combined With CapeOX and Radiotherapy in Patients With Unresectable Metastatic MSS-type Colorectal Cancer: Efficacy and Safety Assessment","Inclusion Criteria:\n\n* Aged 18-75.\n* ECOG performance status of 0-1.\n* Initial diagnosis confirmed by colonoscopy and pathology as colorectal adenocarcinoma.\n* Imaging confirmation of multiple measurable metastases, deemed unresectable initially after MDT discussion.\n* No prior treatment or more than 1 year since completion of initial untreated\u002Fpost-operative adjuvant chemotherapy, and no previous anti-tumor therapy thereafter.\n* With good organ function, without contraindications for surgery or chemotherapy.\n* Prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN, and international normalized ratio (INR) ≤ 1.5 × ULN (if not receiving anticoagulant therapy).\n* Urine protein \\\u003C 2+; if urine protein ≥ 2+, 24-hour urine protein quantitative test must show ≤ 1g protein.\n* Left ventricular ejection fraction (LVEF) ≥ 55%. 12-lead electrocardiogram: Fridericia-corrected QT interval (QTcF) \\\u003C 470 msec.\n* Expected survival \\> 6 months.\n* Clear status of KRAS, NRAS, BRAF, and HER2 genes.\n* Microsatellite stable or mismatch repair protein proficient patients.\n\nExclusion Criteria:\n\n* Age \\\u003C18 years or \\>75 years.\n* History of any other malignancy within 5 years, except adequately treated cervical carcinoma in situ, squamous cell carcinoma of the skin, or basal cell carcinoma that has been effectively controlled.\n* Malignant pleural or peritoneal effusion.\n* Severe internal medical complications preventing chemotherapy or surgery.\n* Clinical or radiological evidence of spinal cord compression, or tumor within 3 mm of the spinal cord on MRI.\n* Imaging-confirmed brain, ovarian, or peritoneal metastases.\n* Patients deemed suitable for aggressive systemic treatment to achieve conversion after MDT discussion.\n* Pathologically diagnosed signet ring cell carcinoma.\n* Patients with microsatellite instability or mismatch repair protein deficiencies.\n* Patients with intestinal obstruction, perforation, bleeding requiring emergency surgical resection.\n* Immunodeficiency diseases, including primary immunodeficiency diseases (genetically determined) or secondary immunodeficiency diseases.\n* Known or suspected interstitial pneumonia.\n* Severe cardiovascular diseases, including but not limited to conditions meeting NYHA class (III or higher), myocardial infarction or cerebrovascular accident (ischemic stroke, symptomatic cerebral infarction) within the past 3 months prior to first dosing, unstable angina or unstable arrhythmias within the past 1 month prior to first dosing, congestive heart failure beyond the above criteria, symptomatic superior vena cava syndrome, etc.\n* Venous thromboembolic events within the past 3 months, such as deep vein thrombosis and pulmonary embolism.\n* History of receiving live attenuated vaccines within 28 days prior to first study drug administration or anticipated need for live attenuated vaccines during the study period.\n* Active hepatitis B (defined as positive hepatitis B surface antigen \\[HBsAg\\] with HBV-DNA ≥500 IU\u002Fml).\n* Hepatitis C (defined as positive hepatitis C virus antibody \\[HCV-Ab\\]).\n* History of tuberculosis infection or treatment within the past 1 year prior to signing informed consent.\n* History of or planned allogeneic bone marrow or solid organ transplantation.\n* Abnormal coagulation function (INR \\> 1.5 or APTT \\> 1.5 × ULN), with bleeding tendency or undergoing thrombolysis or requiring long-term anticoagulant therapy with warfarin or heparin, or requiring long-term antiplatelet therapy (aspirin ≥ 300 mg\u002Fday or clopidogrel ≥ 75 mg\u002Fday).\n* Peripheral neuropathy of Grade ≥2 according to NCI-CTCAE v5.0.\n* Concurrent other infectious diseases unsuitable for participation in this study.",{"count":173,"type":22},36,[25],"This is a prospective, single-arm, single-center Phase II clinical study. In this study, participants will receive Ivosidenib in combination with CapeOX chemotherapy and radiotherapy. The treatment regimen is as follows: participants will first receive Ivosidenib in combination with CapeOX chemotherapy during the first cycle, followed by radiotherapy starting 2 weeks after medication. Depending on the dose limits of normal tissue radiation, Stereotactic Ablative Radiotherapy (SABR), large fraction radiotherapy, or high-dose combined with low-dose radiotherapy will be administered to primary and metastatic lesions. One week after completing radiotherapy, participants will continue to receive Ivosidenib in combination with CapeOX systemic treatment. If extensive primary and metastatic lesions cannot be treated with radiotherapy initially, participants will continue to receive Ivosidenib in combination with CapeOX systemic treatment until the lesions shrink, at which point radiotherapy may be considered.\n\nAssessments will be conducted every 2 treatment cycles after treatment initiation, with multidisciplinary team (MDT) discussions to determine if No Evidence of Disease (NED) is achieved. Patients achieving NED may undergo surgery or local treatment, while those with stable or partial responses will continue combination therapy. Patients with disease progression will discontinue study treatment. Patients ineligible for surgical treatment will continue combination therapy until disease progression or until they exit the study for surgical treatment.\n\nDuring the study period, participants will undergo safety monitoring. The safety follow-up period is defined as 90 days after the last dose of Ivosidenib. Safety data will be collected from the time of informed consent signing until the end of the safety follow-up period or initiation of new anti-tumor treatment (whichever occurs first).",[177,30,178],"CRC","Metastatic Cancer","NOT_YET_RECRUITING","2024-09-10",{"date":182,"type":39},"2024-09-19",{"date":184,"type":22},"2024-11-01",{"date":186,"type":22},"2026-11-01",{"name":188,"class":46},"Fudan University",{"id":190,"slug":191,"hasResults":11,"nctId":192,"briefTitle":193,"officialTitle":194,"acronym":4,"eligibilityCriteria":195,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":196,"targetDuration":4,"studyType":23,"phases":198,"briefSummary":199,"conditions":200,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":203,"lastUpdatePostDateStruct":204,"startDateStruct":206,"completionDateStruct":208,"leadSponsor":210,"locationsCount":47},"100540764","phase-2-ice-study-combination-of-irinotecan-plus-cetuximab-and-envafolimab-as-a-rechallenge-regimen-in-mcrc-100540764","NCT06321081","ICE Study: Combination of Irinotecan Plus Cetuximab and Envafolimab as a Rechallenge Regimen in mCRC","ICE Study: a Clinical Study of the Combination of Irinotecan Plus Cetuximab and Envafolimab as a Rechallenge Regimen in mCRC","Inclusion Criteria:\n\n* Signed written informed consent before any trial-related procedure is undertaken that is not part of the standard patient management.\n\nMale or female subjects aged ≥ 18 years. Histologically proven diagnosis of colorectal adenocarcinoma. Diagnosis of metastatic disease. RAS (NRAS and KRAS exon 2,3 and 4) and BRAF wild-type in liquid biopsy at screening (according to NGS) Efficacy of any front-line therapies containing cetuximab or irinotecan with a major response achieved (i.e. complete or partial response according to RECIST criteria v1.1)..\n\nMore than 2 months since the last dose of cetuximab administered in first line treatment before randomization.\n\nMeasurable disease according to RECIST criteria v1.1. ECOG PS of 0 to 1 at trial entry. Estimated life expectancy of more than 12 weeks. Adequate hematological function defined by white blood cell (WBC) count ≥ 2.5 × 109\u002FL with absolute neutrophil count (ANC) ≥ 1.5 × 109\u002FL, lymphocyte count ≥ 0.5 × 109\u002FL, platelet count ≥ 100 × 109\u002FL, and hemoglobin ≥ 9 g\u002FdL (may have been transfused).\n\nAdequate hepatic function defined by a total bilirubin level ≤ 1.5 × the upper limit of normal (ULN) range and AST and alanine aminotransferase (ALT) levels ≤ 2.5 × ULN for all subjects or AST and ALT levels ≤ 5 x ULN (for subjects with documented metastatic disease to the liver).\n\nAdequate renal function defined by an estimated creatinine clearance \\> 30 mL\u002Fmin according to the Cockcroft-Gault formula (or local institutional standard method).\n\nEffective contraception for both male and female subjects throughout the study and for at least 2 months after last study treatment administration if the risk of conception exists (Note: The effects of the trial drug on the developing human fetus are unknown; thus, women of childbearing potential and men must agree to use effective contraception, defined as 2 barrier methods, or 1 barrier method with a spermicide, an intrauterine device, or use of oral female contraceptive. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this trial, the treating physician should be informed immediately).\n\nExclusion Criteria:\n\n* Any contraindication to cetuximab and\u002For envafolimab. Past or current history of malignancies other than colorectal carcinoma, except for curatively treated basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix.\n\nPregnancy. Breastfeeding. Participation in a clinical study or experimental drug treatment within 30 days before enrollment.\n\nSubjects receiving immunosuppressive agents (such as steroids) for any reason, should be tapered off these drugs before initiation of the trial treatment, with the exception of:\n\nSubjects with adrenal insufficiency, who may continue corticosteroids at physiologic replacement dose, equivalent to ≤ 10 mg prednisone daily Intranasal, inhaled, topical steroids, Local steroid injection (e.g., intra-articular injection) Systemic corticosteroids at physiologic doses ≤ 10 mg\u002Fday of prednisone or equivalent Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication) No ongoing neurological symptoms related to the brain localization of the disease (sequelae that are a consequence of the treatment of the brain metastases are acceptable) Prior organ transplantation, including allogeneic stemcell transplantation\n\nSignificant acute or chronic infections including, among others:\n\nKnown history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome\n\nActive autoimmune disease that might deteriorate when receiving an immunostimulatory agent:\n\nSubjects with diabetes type I, vitiligo, psoriasis, hypo- or hyperthyroid disease not requiring immunosuppressive treatment are eligible.\n\nSubjects requiring hormone replacement with corticosteroids are eligible if steroids are administered only for the purpose of hormonal replacement and at doses ≤ 10 mg or equivalent prednisone per day.\n\nAdministration of steroids through a route known to result in a minimal systemic exposure (topical, intranasal, intro-ocular, or inhalation) are acceptable.\n\nActive infection requiring systemic therapy. Previous or ongoing administration of systemic steroids for the management of an acute allergic phenomenon is acceptable as long as it is anticipated that the administration of steroids will be completed in 14 days, or that the daily dose after 14 days will be ≤ 10 mg per day of equivalent prednisone.\n\nKnown severe hypersensitivity to investigational product or any component in its formulations, including known severe hypersensitivity reactions to monoclonal antibodies (NCI CTCAE v 5 Grade ≥ 3), any history of anaphylaxis, or uncontrolled asthma (that is, 3 or more features of partially controlled asthma).\n\nHistory of hypersensitivity to Polysorbate 80 that led to unacceptable toxicity requiring treatment cessation.\n\nPersisting toxicity related to prior therapy of Grade \\> 1 NCI- CTCAE v 5.0. Known alcohol or drug abuse. Clinically significant (that is active) cardiovascular disease: cerebral vascular accident\u002Fstroke (\\\u003C6 months prior to enrollment), myocardial infarction (\\\u003C6 months prior to enrollment), unstable angina, congestive heart failure (New York Heart Association Classification Class ≥ II), or serious uncontrolled cardiac arrhythmia requiring medication.\n\nHistory of keratitis, ulcerative keratitis or severe dry eye. Since contact lent use is also a risk factor for keratitis and ulceration, it is not recommended.\n\nOther severe acute or chronic medical conditions including immune colitis, inflammatory bowel disease, immune pneumonitis, pulmonary fibrosis or psychiatric conditions including recent (within the past year) or active suicidal ideation or behavior; or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.\n\nLegal incapacity or limited legal capacity.",{"count":197,"type":22},60,[25],"This is a non-profit phase II, open, clinical study of the combination of irinotecan plus cetuximab and envafolimab as a rechallenge regimen, in pre-treated RAS\u002FBRAF wild type metastatic colorectal cancer patients (according to liquid biopsy at baseline). Patients have been treated in front lines with irinotecan and cetuximab and had a clinical benefit (complete or partial response) from both of them, no matter whether they had treated by any PD-1 inhibitor before.",[201,202,30],"RAS Mutation","Metastatic Colorectal Cancer","2024-03-14",{"date":205,"type":39},"2024-03-20",{"date":207,"type":39},"2024-03-01",{"date":209,"type":22},"2026-08-14",{"name":211,"class":212},"Beijing Hospital","OTHER_GOV",{"id":214,"slug":215,"hasResults":11,"nctId":216,"briefTitle":217,"officialTitle":217,"acronym":4,"eligibilityCriteria":218,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":219,"targetDuration":4,"studyType":23,"phases":221,"briefSummary":223,"conditions":224,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":228,"lastUpdatePostDateStruct":229,"startDateStruct":231,"completionDateStruct":233,"leadSponsor":235,"locationsCount":47},"100506683","toripalimab-combined-with-neoadjuvant-chemoradiotherapy-as-first-line-treatment-for-locally-advancedhigh-riskmss-rectal-cancer-100506683","NCT05877573","Toripalimab Combined With Neoadjuvant Chemoradiotherapy as First-line Treatment for Locally Advanced，High-Risk，MSS Rectal Cancer","Inclusion Criteria:\n\n* Age 18-75 years old, female and male;\n* Pathological confirmed MSS or pMMR rectal adenocarcinoma;\n* Clinical stage T3-4 (AJCC 8th) and at least with one high risk factor（CRM+ or EMVI+ or lateral lymph nodes+）;\n* No previous chemotherapy, radiotherapy, immunotherapy or other anti-tumor treatment;\n* Adequate organ function defined at baseline as:\n\nANC ≥1.5××109\u002FL，PLt ≥100×109 \u002FL，Hb ≥90 g\u002FL，15×109 \u002FL≥WBC≥4×109 \u002FL; TBIL ≤1.5×ULN, ALT ≤1.5ULN, AST ≤1.5ULN, BUN and Cr ≤1.5×ULN or Ccr\n\n* 60ml\u002Fmin (Cockcroft-Gault formula);INR ≤1.5×ULN or PT ≤1.5×ULN (when patient didn't accept anticoagulant therapy);\n\n  * Women of childbearing age must have taken reliable contraceptive measures or have a pregnancy test (serum or urine) within 7 days prior to enrollment and the results are negative;\n\nExclusion Criteria:\n\n* Pathological confirmed rectal squamous cell carcinoma;\n* History of other uncured malignancies within 5 years;\n* Allergic to any component of chemotherapy or immunotherapy;\n* History of any active, known, or suspected autoimmune disease, including but not limited to myasthenia gravis,Myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis,Inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener granulation Swollen disease, Sjogren's syndrome, Guillain-Barre syndrome, multiple sclerosis, vasculitis or Glomerulonephritis.\n* With congenital or acquired immunodeficiency (such as those with HIV infection), active hepatitis B or hepatitis C;",{"count":220,"type":22},53,[222],"NA","This is a single arm, open-label, prospective clinical trial to evaluate the combination of neoadjuvant short-course radiotherapy and toripalimab (PD-1 antibody) for locally advanced rectal cancer (LARC) patients with high risk factors. A total of 53patients will be enrolled in this trial to receive 5\\*5Gy short-course radiotherapy, followed by 4 cycles of CAPOX chemotherapy and PD-1 antibody. Then they will receive the TME surgery and another 2 cycles of CAPOX chemotherapy. The primary end point is the rate of pathological complete response (pCR). The long-term prognosis and adverse effects will also be evaluated and analyzed.",[225,226,227,30],"Locally Advanced","High-Risk","Rectal Cancer","2023-07-02",{"date":230,"type":39},"2023-07-05",{"date":232,"type":22},"2023-07-01",{"date":234,"type":22},"2026-08-01",{"name":236,"class":46},"Nanfang Hospital, Southern Medical University"]